Viewing Study NCT01101035

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Ignite Creation Date: 2025-12-24 @ 10:03 PM
Ignite Modification Date: 2025-12-30 @ 1:16 AM
Study NCT ID: NCT01101035
Status: COMPLETED
Last Update Posted: 2018-06-14
First Post: 2010-04-07
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069465', 'term': 'Febuxostat'}, {'id': 'D000493', 'term': 'Allopurinol'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Febuxostat', 'description': 'Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.', 'otherNumAtRisk': 3098, 'deathsNumAtRisk': 3098, 'otherNumAffected': 1450, 'seriousNumAtRisk': 3098, 'deathsNumAffected': 243, 'seriousNumAffected': 1046}, {'id': 'EG001', 'title': 'Allopurinol', 'description': 'Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \\[eCLcr\\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \\<60 mL/min).', 'otherNumAtRisk': 3092, 'deathsNumAtRisk': 3092, 'otherNumAffected': 1467, 'seriousNumAtRisk': 3092, 'deathsNumAffected': 199, 'seriousNumAffected': 995}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 157}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 125}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 299}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 284}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 132}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 168}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 183}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 214}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 212}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 242}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 267}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 146}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 180}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 161}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 258}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 311}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 216}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 187}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 159}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 222}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 218}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 209}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 261}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}], 'seriousEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Immune thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Aortic valve calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Aortic valve sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bifascicular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Defect conduction intraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiac ventricular thrombosis', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiovascular disorder', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypertensive heart disease', 'notes': 'Three treatment-emergent deaths occurred during treatment with febuxostat and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Malignant hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiac discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiac valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Heart valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ischaemic cardiomyopathy', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Arteriosclerosis coronary artery', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Coronary artery disease', 'notes': 'Two treatment-emergent deaths occurred during treatment with febuxostat and are not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 58}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiac failure', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiac failure acute', 'notes': 'Two treatment-emergent deaths occurred during treatment with febuxostat and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiac failure chronic', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiac failure congestive', 'notes': 'Ten treatment-emergent deaths occurred during treatment with febuxostat and are not related; Eight treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 109}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiogenic shock', 'notes': 'Two treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiopulmonary failure', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Acute coronary syndrome', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Acute myocardial infarction', 'notes': 'Five treatment-emergent deaths occurred during treatment with febuxostat and are not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 68}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 33}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Myocardial infarction', 'notes': 'Eleven treatment-emergent deaths occurred during treatment with febuxostat and are not related; Seven treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 51}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Myocardial ischaemia', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Silent myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Subendocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Mitral valve prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiac aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiac hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Systolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Arrhythmia', 'notes': 'Two treatment-emergent deaths occurred during treatment with febuxostat and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Chronotropic incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cor pulmonale', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Right ventricular failure', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Atrial fibrillation', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 64}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Atrial flutter', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Accelerated idioventricular rhythm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardiac arrest', 'notes': 'Eleven treatment-emergent deaths occurred during treatment with febuxostat and are not related; Eight treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardio-respiratory arrest', 'notes': 'Four treatment-emergent deaths occurred during treatment with febuxostat and are not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pulseless electrical activity', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ventricular arrhythmia', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ventricular fibrillation', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ventricular tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ventricular tachycardia', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 25}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cystic lymphangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Adrenocortical insufficiency acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Blindness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Sudden visual loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Abdominal hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Abdominal wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Alcoholic pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Duodenal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pancreatic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Poor dental condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diarrhoea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Volvulus of small bowel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Duodenal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Haemorrhagic erosive gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diabetic gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Oesophageal achalasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Enterocutaneous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Oesophageal food impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastrointestinal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastrointestinal angiodysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intestinal ischaemia', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Colonic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Mesenteric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Large intestine perforation', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Vomiting projectile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastrointestinal haemorrhage', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Oesophageal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Erosive oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Oesophageal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Varices oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Retroperitoneal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Incarcerated umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Medical device pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Accidental death', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Death', 'notes': 'Five treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Drowning', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Sudden cardiac death', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Sudden death', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Multiple organ dysfunction syndrome', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Strangulated hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Implant site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Systemic inflammatory response syndrome', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Haemorrhagic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Necrobiosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Surgical failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Vascular stent occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Vascular stent restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 8}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 9}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Biliary dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Acute hepatic failure', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hepatic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Granulomatous liver disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Colonic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cellulitis of male external genital organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Endocarditis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastroenteritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Incisional hernia gangrenous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Meningitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Oral bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pneumonia bacterial', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bursitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Osteomyelitis', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Osteomyelitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pertussis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lyme disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Oropharyngeal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'CNS ventriculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gas gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Sialoadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Vulval abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Helicobacter gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Herpes simplex meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Herpes zoster meningomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Varicella zoster virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Abscess rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Groin abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Groin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Implant site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Incision site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Infected bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Injection site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Mediastinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Medical device site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Postoperative abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Influenza', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pneumonia legionella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pneumonia', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; Six treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 88}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pneumonia necrotising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Necrotising fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Proteus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pseudomonal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Sepsis', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Septic embolus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Septic shock', 'notes': 'Two treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Carbuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diabetic foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Infected skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cellulitis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Endocarditis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Staphylococcal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Staphylococcal parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Beta haemolytic streptococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cellulitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pneumonia streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Streptococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cellulitis pharyngeal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Upper respiratory tract infection', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lymphangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bronchitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Encephalitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Splenic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Coronary artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Post procedural myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Vascular pseudoaneurysm', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Vascular injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Epidural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Extradural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Subdural haematoma', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pneumothorax traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Exposure to toxic agent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Open globe injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Open fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intestinal anastomosis complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Postoperative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hip fracture', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Scapula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Psychosis postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Fall', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gun shot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Multiple injuries', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Post concussion syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Road traffic accident', 'notes': 'Three treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Failure to anastomose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Incisional hernia, obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Post procedural haemorrhage', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Procedural hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Procedural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Toxicity to various agents', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Postoperative respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Postoperative thoracic procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Tracheostomy malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Head injury', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Scrotal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Burns second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Prothrombin time ratio decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Electrocardiogram T wave abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Electrocardiogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Occult blood positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Heart rate irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Computerised tomogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Laboratory test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Blood creatine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cardioactive drug level increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Influenza B virus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diabetic complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hyperglycaemic hyperosmolar nonketotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hyperosmolar state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Fluid overload', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Neuropathic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Exostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Chondrocalcinosis pyrophosphate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Muscle haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 34}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Vertebral osteophyte', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Anal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'B-cell lymphoma stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bladder cancer', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bladder transitional cell carcinoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Breast cancer female', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Invasive lobular breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Brain neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diffuse large B-cell lymphoma', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Parathyroid tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pleomorphic malignant fibrous histiocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Adenocarcinoma gastric', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Large intestine benign neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastrointestinal stromal tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastrointestinal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hepatic cancer', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hepatocellular carcinoma', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hepatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Laryngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Chronic myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Benign salivary gland neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Squamous cell carcinoma of the oral cavity', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Benign anorectal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lymphoma', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Metastases to central nervous system', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Metastases to pleura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Chronic myelomonocytic leukaemia', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Myelodysplastic syndrome', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Myelofibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Polycythaemia vera', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Adenocarcinoma', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Adenosquamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Head and neck cancer', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Squamous cell carcinoma', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lung adenocarcinoma', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lung adenocarcinoma stage IV', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lung squamous cell carcinoma stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Non-small cell lung cancer metastatic', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Malignant neoplasm of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Oesophageal adenocarcinoma', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Oesophageal carcinoma', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Tumour ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ductal adenocarcinoma of pancreas', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pancreatic carcinoma', 'notes': 'Three treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pancreatic carcinoma metastatic', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Squamous cell carcinoma of pharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Prostate cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Prostate cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Kidney angiomyolipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lung cancer metastatic', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lung carcinoma cell type unspecified stage IV', 'notes': 'Two treatment-emergent deaths occurred during treatment with febuxostat and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lung neoplasm malignant', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; Three treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Malignant melanoma stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Metastatic malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Neuroendocrine carcinoma of the skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Poorly differentiated thyroid carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Benign neoplasm of bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Petit mal epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Brain stem stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cerebral haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cerebral haemorrhage', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cerebral infarction', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cerebrovascular accident', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 44}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Haemorrhage intracranial', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Haemorrhagic transformation stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ischaemic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lacunar stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Thalamic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Thalamus haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Thrombotic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Carotid arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Carotid artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cervical myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diabetic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Encephalitis autoimmune', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypertensive encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypoxic-ischaemic encephalopathy', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypoglycaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Uraemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cluster headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Normal pressure hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cerebrospinal fluid leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Quadriparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Slow speech', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Nerve root compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Spinal claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Spinal cord disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Spondylitic myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cerebral ventricle dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Device lead issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Device battery issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Device lead damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Delirium tremens', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Shared psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Substance use disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Completed suicide', 'notes': 'Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intentional self-injury', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Suicidal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bladder outlet obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Urinary bladder haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Renal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Renal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Acute kidney injury', 'notes': 'Three treatment-emergent deaths occurred during treatment with allopurinol and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 139}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 132}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Renal failure', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 19}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Malignant renal hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Renal artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Renal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Vaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pelvic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Prostatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Female genital tract fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Respiratory arrest', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bronchiectasis', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 35}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Respiratory acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Laryngeal dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Alveolitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pneumonia aspiration', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pulmonary sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pulmonary fibrosis', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Restrictive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pulmonary arterial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pulmonary hypertension', 'notes': 'One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Acute respiratory distress syndrome', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pulmonary oedema', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pulmonary embolism', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Pulmonary infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Acute respiratory failure', 'notes': 'Seven treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 43}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Chronic respiratory failure', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related. One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Respiratory failure', 'notes': 'Five treatment-emergent deaths occurred during treatment with febuxostat and are not related; Seven treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Blood blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Dermatitis exfoliative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Diabetic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Leg amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Aortic occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Aortic stenosis', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Leriche syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypovolaemic shock', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Shock', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Embolism venous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Arteriosclerosis', 'notes': 'One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Vascular occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Arterial rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Dry gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Poor peripheral circulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Aortic calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Essential hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 16}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Neuroendocrine tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 59}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}, {'term': 'Gastrointestinal angiodysplasia haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3098, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3092, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version: 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Primary Major Adverse Cardiovascular Events (MACE) Composite (75% Interim Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3039', 'groupId': 'OG000'}, {'value': '3034', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat', 'description': 'Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.'}, {'id': 'OG001', 'title': 'Allopurinol', 'description': 'Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \\[eCLcr\\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \\<60 mL/min).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97', 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medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Cardiovascular (CV) Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'OG000'}, {'value': '3092', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat', 'description': 'Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.'}, {'id': 'OG001', 'title': 'Allopurinol', 'description': 'Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \\[eCLcr\\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \\<60 mL/min).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.73', 'estimateComment': 'Time from randomization to the first occurrence of cardiovascular death was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to last dose of study drug (approximately 83 months)', 'description': 'Events were adjudicated by an independent cardiovascular endpoints committee as CV death.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Non-fatal Myocardial Infarction (MI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'OG000'}, {'value': '3092', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat', 'description': 'Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.'}, {'id': 'OG001', 'title': 'Allopurinol', 'description': 'Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \\[eCLcr\\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \\<60 mL/min).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.21', 'estimateComment': 'Time from randomization to the first occurrence of non-fatal MI was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to last dose of study drug (approximately 83 months)', 'description': 'Events were adjudicated by an independent cardiovascular endpoints committee as non-fatal MI.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Non-fatal Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'OG000'}, {'value': '3092', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat', 'description': 'Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.'}, {'id': 'OG001', 'title': 'Allopurinol', 'description': 'Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \\[eCLcr\\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \\<60 mL/min).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.41', 'estimateComment': 'Time from randomization to the first occurrence of non-fatal stroke was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to last dose of study drug (approximately 83 months)', 'description': 'Events were adjudicated by an independent cardiovascular endpoints committee as non-fatal stroke.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Unstable Angina With Urgent Coronary Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'OG000'}, {'value': '3092', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat', 'description': 'Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.'}, {'id': 'OG001', 'title': 'Allopurinol', 'description': 'Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function 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(approximately 83 months)', 'description': 'Events were adjudicated by an independent cardiovascular endpoints committee as unstable angina with urgent coronary revascularization.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Primary MACE Composite (Final Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'OG000'}, {'value': '3092', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat', 'description': 'Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.'}, {'id': 'OG001', 'title': 'Allopurinol', 'description': 'Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \\[eCLcr\\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \\<60 mL/min).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '10.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97', 'paramValue': '1.03', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.23', 'estimateComment': 'Time from randomization to the first occurrence of any MACE was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal 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approximately 82 months.'}, {'id': 'FG001', 'title': 'Allopurinol', 'description': 'Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \\[eCLcr\\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \\<60 mL/min).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3101'}, {'groupId': 'FG001', 'numSubjects': '3097'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1704'}, {'groupId': 'FG001', 'numSubjects': '1706'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1397'}, {'groupId': 'FG001', 'numSubjects': '1391'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '191'}, {'groupId': 'FG001', 'numSubjects': '172'}]}, {'type': 'Major Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '226'}, {'groupId': 'FG001', 'numSubjects': '223'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '595'}, {'groupId': 'FG001', 'numSubjects': '587'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '333'}, {'groupId': 'FG001', 'numSubjects': '363'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 320 investigative sites in Canada, Mexico and United States from 23 April 2010 to 18 July 2017.', 'preAssignmentDetails': 'Participants with a diagnosis of gout and significant cardiovascular comorbidities were enrolled in a 1:1 ratio to receive either febuxostat or allopurinol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Febuxostat', 'description': 'Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.'}, {'id': 'BG001', 'title': 'Allopurinol', 'description': 'Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \\[eCLcr\\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \\<60 mL/min).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.6', 'spread': '8.58', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '8.49', 'groupId': 'BG001'}, {'value': '64.8', 'spread': '8.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1584', 'groupId': 'BG000'}, {'value': '1506', 'groupId': 'BG001'}, {'value': '3090', 'groupId': 'BG002'}]}]}, {'title': '65 to <75 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1094', 'groupId': 'BG000'}, {'value': '1135', 'groupId': 'BG001'}, {'value': '2229', 'groupId': 'BG002'}]}]}, {'title': '≥75 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '420', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '871', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '494', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '994', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2604', 'groupId': 'BG000'}, {'value': '2592', 'groupId': 'BG001'}, {'value': '5196', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '496', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '552', 'groupId': 'BG000'}, {'value': '593', 'groupId': 'BG001'}, {'value': '1145', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2160', 'groupId': 'BG000'}, {'value': '2140', 'groupId': 'BG001'}, {'value': '4300', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '539', 'groupId': 'BG000'}, {'value': '521', 'groupId': 'BG001'}, {'value': '1060', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2559', 'groupId': 'BG000'}, {'value': '2571', 'groupId': 'BG001'}, {'value': '5130', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '379', 'groupId': 'BG000'}, {'value': '355', 'groupId': 'BG001'}, {'value': '734', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2651', 'groupId': 'BG000'}, {'value': '2665', 'groupId': 'BG001'}, {'value': '5316', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '172.9', 'spread': '9.54', 'groupId': 'BG000'}, {'value': '173.0', 'spread': '9.77', 'groupId': 'BG001'}, {'value': '173.0', 'spread': '9.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3087', 'groupId': 'BG001'}, {'value': '6185', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '100.5', 'spread': '22.47', 'groupId': 'BG000'}, {'value': '100.3', 'spread': '22.89', 'groupId': 'BG001'}, {'value': '100.4', 'spread': '22.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here, number analyzed indicates participants who were evaluated for this baseline characteristic.'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3087', 'groupId': 'BG001'}, {'value': '6185', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32.5', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '73'}, {'value': '32.1', 'groupId': 'BG001', 'lowerLimit': '17', 'upperLimit': '75'}, {'value': '32.3', 'groupId': 'BG002', 'lowerLimit': '17', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'description': 'Body Mass Index = weight (kg)/\\[height (m)\\^2\\]', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Here, number analyzed indicates participants who were evaluated for this baseline characteristic.'}, {'title': 'BMI Categorical', 'classes': [{'title': '<25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}]}, {'title': '25-30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '844', 'groupId': 'BG000'}, {'value': '862', 'groupId': 'BG001'}, {'value': '1706', 'groupId': 'BG002'}]}]}, {'title': '≥30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2053', 'groupId': 'BG000'}, {'value': '2024', 'groupId': 'BG001'}, {'value': '4077', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Body Mass Index = weight (kg)/\\[height (m)\\^2\\]', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking History', 'classes': [{'title': 'Never smoked', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1175', 'groupId': 'BG000'}, {'value': '1124', 'groupId': 'BG001'}, {'value': '2299', 'groupId': 'BG002'}]}]}, {'title': 'Ex-smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1533', 'groupId': 'BG000'}, {'value': '1553', 'groupId': 'BG001'}, {'value': '3086', 'groupId': 'BG002'}]}]}, {'title': 'Current smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '390', 'groupId': 'BG000'}, {'value': '415', 'groupId': 'BG001'}, {'value': '805', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol History', 'classes': [{'title': 'Never drank', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '792', 'groupId': 'BG000'}, {'value': '784', 'groupId': 'BG001'}, {'value': '1576', 'groupId': 'BG002'}]}]}, {'title': 'Ex-drinker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '805', 'groupId': 'BG000'}, {'value': '812', 'groupId': 'BG001'}, {'value': '1617', 'groupId': 'BG002'}]}]}, {'title': 'Current drinker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1501', 'groupId': 'BG000'}, {'value': '1496', 'groupId': 'BG001'}, {'value': '2997', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Renal Function', 'classes': [{'title': 'Moderately Impaired', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1636', 'groupId': 'BG000'}, {'value': '1631', 'groupId': 'BG001'}, {'value': '3267', 'groupId': 'BG002'}]}]}, {'title': 'Mildly Impaired', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1217', 'groupId': 'BG000'}, {'value': '1231', 'groupId': 'BG001'}, {'value': '2448', 'groupId': 'BG002'}]}]}, {'title': 'Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '239', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '467', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Moderate renal impairment: eCLcr=30 to 59 mL/min; mild renal impairment: eCLcr=60 to 89 mL/min; normal: eCLcr ≥90 mL/min. Seven subjects with Baseline eCLcr \\<30 mL/min and 1 subject with missing Baseline eCLcr', 'unitOfMeasure': 'Participants'}, {'title': 'History of Kidney Stone', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '627', 'groupId': 'BG000'}, {'value': '627', 'groupId': 'BG001'}, {'value': '1254', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2471', 'groupId': 'BG000'}, {'value': '2465', 'groupId': 'BG001'}, {'value': '4936', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Use of Low Dose Aspirin', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1496', 'groupId': 'BG000'}, {'value': '1481', 'groupId': 'BG001'}, {'value': '2977', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1602', 'groupId': 'BG000'}, {'value': '1611', 'groupId': 'BG001'}, {'value': '3213', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Dosing \\<325 mg aspirin per day is considered as low-dose aspirin', 'unitOfMeasure': 'Participants'}, {'title': 'Use of any Dose of Aspirin', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1894', 'groupId': 'BG000'}, {'value': '1933', 'groupId': 'BG001'}, {'value': '3827', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1204', 'groupId': 'BG000'}, {'value': '1159', 'groupId': 'BG001'}, {'value': '2363', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Use of Nonsteroidal Anti-Inflammatory Drug (NSAIDs)', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '856', 'groupId': 'BG000'}, {'value': '908', 'groupId': 'BG001'}, {'value': '1764', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2242', 'groupId': 'BG000'}, {'value': '2184', 'groupId': 'BG001'}, {'value': '4426', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Use of Clopidogrel and Other Antiplatelet Drugs', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '599', 'groupId': 'BG000'}, {'value': '627', 'groupId': 'BG001'}, {'value': '1226', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3098', 'groupId': 'BG000'}, {'value': '3092', 'groupId': 'BG001'}, {'value': '6190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2499', 'groupId': 'BG000'}, {'value': '2465', 'groupId': 'BG001'}, {'value': '4964', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-08-27', 'size': 1518045, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-11T12:01', 'hasProtocol': True}, {'date': '2017-02-22', 'size': 683710, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-11T12:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-12', 'studyFirstSubmitDate': '2010-04-07', 'resultsFirstSubmitDate': '2018-05-11', 'studyFirstSubmitQcDate': '2010-04-07', 'lastUpdatePostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-12', 'studyFirstPostDateStruct': {'date': '2010-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Primary Major Adverse Cardiovascular Events (MACE) Composite (75% Interim Analysis)', 'timeFrame': 'Up to last dose of study drug (approximately 83 months)', 'description': 'Major adverse cardiovascular events (MACE) were defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), nonfatal stroke and unstable angina with urgent coronary revascularization; these events were adjudicated by an independent cardiovascular endpoints committee.'}, {'measure': 'Percentage of Participants With Primary MACE Composite (Final Analysis)', 'timeFrame': 'Up to last dose of study drug (approximately 83 months)', 'description': 'Major adverse cardiovascular events (MACE) were defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), nonfatal stroke and unstable angina with urgent coronary revascularization; these events were adjudicated by an independent cardiovascular endpoints committee.'}], 'secondaryOutcomes': [{'measure': "Percentage of Participants With Antiplatelet Trialists' Collaborative (APTC) Event", 'timeFrame': 'Up to last dose of study drug (approximately 83 months)', 'description': 'APTC events were defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.'}, {'measure': 'Percentage of Participants With Cardiovascular (CV) Death', 'timeFrame': 'Up to last dose of study drug (approximately 83 months)', 'description': 'Events were adjudicated by an independent cardiovascular endpoints committee as CV death.'}, {'measure': 'Percentage of Participants With Non-fatal Myocardial Infarction (MI)', 'timeFrame': 'Up to last dose of study drug (approximately 83 months)', 'description': 'Events were adjudicated by an independent cardiovascular endpoints committee as non-fatal MI.'}, {'measure': 'Percentage of Participants With Non-fatal Stroke', 'timeFrame': 'Up to last dose of study drug (approximately 83 months)', 'description': 'Events were adjudicated by an independent cardiovascular endpoints committee as non-fatal stroke.'}, {'measure': 'Percentage of Participants With Unstable Angina With Urgent Coronary Revascularization', 'timeFrame': 'Up to last dose of study drug (approximately 83 months)', 'description': 'Events were adjudicated by an independent cardiovascular endpoints committee as unstable angina with urgent coronary revascularization.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiovascular Outcomes', 'Heart Attack', 'Stroke', 'Drug Therapy', 'Physiology', 'Hyperuricemia', 'Uric Acid'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '22795277', 'type': 'RESULT', 'citation': 'White WB, Chohan S, Dabholkar A, Hunt B, Jackson R. Cardiovascular safety of febuxostat and allopurinol in patients with gout and cardiovascular comorbidities. Am Heart J. 2012 Jul;164(1):14-20. doi: 10.1016/j.ahj.2012.04.011. Epub 2012 Jun 13.'}, {'pmid': '29527974', 'type': 'RESULT', 'citation': 'White WB, Saag KG, Becker MA, Borer JS, Gorelick PB, Whelton A, Hunt B, Castillo M, Gunawardhana L; CARES Investigators. Cardiovascular Safety of Febuxostat or Allopurinol in Patients with Gout. N Engl J Med. 2018 Mar 29;378(13):1200-1210. doi: 10.1056/NEJMoa1710895. Epub 2018 Mar 12.'}, {'pmid': '35536764', 'type': 'DERIVED', 'citation': 'Saag KG, Becker MA, White WB, Whelton A, Borer JS, Gorelick PB, Hunt B, Castillo M, Gunawardhana L; CARES Investigators. Evaluation of the Relationship Between Serum Urate Levels, Clinical Manifestations of Gout, and Death From Cardiovascular Causes in Patients Receiving Febuxostat or Allopurinol in an Outcomes Trial. Arthritis Rheumatol. 2022 Sep;74(9):1593-1601. doi: 10.1002/art.42160. Epub 2022 Aug 5.'}, {'pmid': '21849262', 'type': 'DERIVED', 'citation': 'Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.'}], 'seeAlsoLinks': [{'url': 'http://general.takedapharm.com/content/file.aspx?applicationcode=6C7C39D8-5D09-453B-BF30-696A4AB88E62&fileTypeCode=ULORICPI', 'label': 'Uloric Package Insert'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see whether subjects with gout who receive febuxostat or allopurinol for up to 9 years have a higher rate of serious heart and blood vessel complications (major cardiovascular events).', 'detailedDescription': 'The drug tested in this study was called Febuxostat (TMX-67). Febuxostat compared with allopurinol was evaluated for the cardiovascular (CV) safety in people with gout and significant CV comorbidities.\n\nThe study enrolled 6198 patients. Participants with a diagnosis of gout were enrolled in a 1:1 ratio to receive either:\n\n* Febuxostat\n* Allopurinol\n\nParticipants received febuxostat 40 mg or 80 mg for the study depending on their serum uric acid levels were either \\<6.0 mg/dL or ≥6.0 mg/dL during specified visits. Allopurinol 200 mg to 400 mg (for moderate renal impairment),or 300 mg to 600 mg (for normal and mild renal impairment), increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL was received.\n\nThis multi-center trial was conducted in Canada, Mexico and United States. The overall time to participate in this study was approximately 7 years (84 months). Participants made multiple visits to the clinic and were also contacted through the telephone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The participant or the participant's legally acceptable representative signs and dates a written, informed consent form/Health Insurance Portability and Accountability Act (HIPAA) Authorization prior to the initiation of any study procedures.\n2. The participant is male ≥50 years of age or female ≥55 years of age and at least 2-years post-menopausal.\n3. The participant has a history of major CV or cerebrovascular disease including at least one of the following:\n\n * Myocardial infarction (MI).\n * Hospitalized unstable angina.\n * Cardiac or cerebrovascular revascularization procedure.\n * Stroke.\n * Hospitalized transient ischemic attack (TIA).\n * Peripheral vascular disease (ankle brachial index ≤0.6, revascularization and/or well-documented history of claudication).\n * History of diabetes mellitus with evidence of micro- or macrovascular disease (retinopathy, neuropathy, nephropathy, small vessel vascular diseases).\n4. The participant has a history or presence of gout defined as having one or more of the American Rheumatism Association criteria for the diagnosis of gout:\n\n * A tophus proven to contain urate crystals by chemical or polarized light microscopic means, and/or\n * Characteristic urate crystals in the joint fluid, and/or\n * History of at least 6 of the following clinical, laboratory, and X-ray phenomena:\n\n * More than 1 attack of acute arthritis.\n * Maximum inflammation developed within 1 day.\n * Monoarticular arthritis.\n * Redness observed over joints.\n * First metatarsophalangeal joint painful or swollen.\n * Unilateral first metatarsophalangeal joint attack.\n * Unilateral tarsal joint attack.\n * Tophus (proven or suspected).\n * Hyperuricemia.\n * Asymmetric swelling within a joint on x-ray.\n * Subcortical cysts without erosions on x-ray.\n * Joint fluid culture negative for organisms during attack.\n5. The participants must have either:\n\n * a serum urate or serum uric acid (sUA) level ≥7.0 mg/dL (≥416 μmol/L) at the Day -7 Visit OR\n * a sUA level ≥6.0 mg/dL (≥354 μmol/L) at the Day -7 Visit AND inadequately controlled gout (≥1 flare in the 12 months prior to screening and/or the presence of tophi).\n6. The participant is capable of understanding and complying with protocol requirements\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will not qualify for entry into this study:\n\n1. The participant has secondary hyperuricemia (eg, due to myeloproliferative disorder, or organ transplant).\n2. The participant has a history of xanthinuria.\n3. The participant has received urate-lowering therapy (i.e., febuxostat, allopurinol, probenecid, etc.) or excluded medication during the screening period (beginning with Day -7).\n4. The participant has a known hypersensitivity to febuxostat or allopurinol or any components of their formulation.\n5. The participant has active peptic ulcer disease.\n6. The participant has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the first dose of study medication.\n7. The participant had MI or stroke within 60 days prior to the Screening Visit.\n8. The participant has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values greater than 2 times the upper limit of normal (×ULN) during the Screening period.\n9. The participant has a significant medical condition and/or conditions that would interfere with the treatment, safety, or compliance with the protocol.\n10. The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 5 years prior to the Screening Visit or the participant consumes \\>14 alcoholic beverages per week.\n11. The participant has received any investigational medicinal product within the 30 days prior to the Screening Visit and throughout the study.\n12. The participant's estimated creatinine clearance (CLcr) is \\<30 mL/min, where CLcr is calculated using the Cockcroft and Gault formula based on ideal body weight (IBW),\n13. The participant is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.\n14. The participant is required to take excluded medications\n15. The participant has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus."}, 'identificationModule': {'nctId': 'NCT01101035', 'acronym': 'CARES', 'briefTitle': 'Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in Subjects With Gout and Cardiovascular Comorbidities', 'orgStudyIdInfo': {'id': 'TMX-67_301'}, 'secondaryIdInfos': [{'id': 'U1111-1114-4194', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Febuxostat', 'description': 'Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.', 'interventionNames': ['Drug: Febuxostat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Allopurinol', 'description': 'Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \\[eCLcr\\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \\<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \\<60 mL/min).', 'interventionNames': ['Drug: Allopurinol']}], 'interventions': [{'name': 'Febuxostat', 'type': 'DRUG', 'otherNames': ['Uloric', 'TMX-67'], 'description': 'Febuxostat tablets', 'armGroupLabels': ['Febuxostat']}, {'name': 'Allopurinol', 'type': 'DRUG', 'otherNames': ['Zyloprim', 'Allohexal', 'Allosig', 'Milurit', 'Alloril', 'Progout', 'Zyloric', 'Puricos', 'Zyrik 300', 'Aluron'], 'description': 'Allopurinol tablets', 'armGroupLabels': ['Allopurinol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'city': 'Dunwoody', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.94621, 'lon': -84.33465}}, {'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'city': 'Norcross', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.94121, 'lon': -84.21353}}, {'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'city': 'Suwanee', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 34.05149, 'lon': -84.0713}}, {'city': 'Waycross', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 31.21368, 'lon': -82.3557}}, {'city': 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